The Essential Role of

Laboratory Professionals
Ensuring the Safety and Effectiveness of
Laboratory Data in Electronic Health Record Systems
May 2014

Center for Surveillance, Epidemiology, and Laboratory Services

Division of Laboratory Programs, Standards, and Services

The Essential Role of Laboratory Professionals: Ensuring the Safety and Effectiveness of Laboratory
Data in Electronic Health Record Systems is a publication of the Division of Laboratory Programs,
Standards and Services in the Center for Surveillance, Epidemiology and Laboratory Services, within
the Centers for Disease Control and Prevention.

Centers for Disease Control and Prevention

Thomas R. Frieden, MD, MPH, Director
Office of Public Health Scientific Services
Chesley Richards, MD, MPH, Deputy Director
Center for Surveillance, Epidemiology and Laboratory Services
Michael F. Iademarco, MD, MPH, Director
Division of Laboratory Programs, Standards and Services
Shambavi Subbarao, PhD, Director

Suggested Citation
Sawchuk, M., Linville, M., Cornish, N., Pollock, A., Lubin, I., Gagnon, M., and Stinn, J. The Essential Role
of Laboratory Professionals: Ensuring the Safety and Effectiveness of Laboratory Data in Electronic Health
Record Systems. Atlanta, GA: Center for Surveillance, Epidemiology and Laboratory Services, Centers
for Disease Control and Prevention; May 2014. Retrieved from http://www.cdc.gov/labhit/paper/
Laboratory_Data_in_EHRs_2014.pdf
For more information, please contact
Centers for Disease Control and Prevention
Division of Laboratory Programs, Standards and Services
1600 Clifton Road, Mailstop F-11
Atlanta, GA 30333, USA
Phone: 404-498-2290
Email: LabHIT@cdc.gov
Web: h
 ttp://www.cdc.gov/LabHIT
http://wwwn.cdc.gov/CLIA

Website addresses of nonfederal organizations cited in this document are provided solely as a service
to readers. Provision of an address does not constitute an endorsement of the organization by CDC or
the federal government, and none should be inferred. CDC is not responsible for the content of other
organizations web pages.

PURPOSE
The development of electronic health record (EHR) systems and other health information technologies
is changing how laboratory data are transmitted and displayed throughout the healthcare system. The
purpose of this paper is to provide an overview of the key areas in which laboratory professionals can
contribute their expertise to the development of accurate exchange and display of laboratory data
in EHR systems. Thoughtfully designed and rigorously tested EHR systems improve patient care by
making it easier to collect, share, and interpret patient data. However, variations in EHR system design,
functionality, and ability to exchange data accurately (interoperability) can also cause preventable
patient safety risks. Examples of preventable patient safety risks include misdiagnosis, delays in
treatment, and inappropriate treatment. These patient safety risks may unintentionally result in patient
injury or even death. For the purpose of this paper, an EHR is safe and effective for laboratory data
when the display of information and the computer systems behaviors (such as critical result alerts) are
developed and implemented to optimally ensure accurate and timely interpretation by the end user.
The purpose of this paper is to illustrate the seriousness of laboratory data-related interoperability
issues and display discrepancies in EHR systems, and propose focus areas for action by laboratory
professionals to support resolving those issues. Through collaboration, laboratory professionals,
clinicians, healthcare executives, medical professional societies, health IT developers, and federal
agencies like the Office of the National Coordinator for Health Information Technology (ONC), the
Centers for Medicare and Medicaid Services (CMS), and the Food and Drug Administration (FDA), can
work together to develop effective solutions to reduce identified patient safety risks in and improve
the safety of EHR systems.

BACKGROUND
National efforts are underway to implement EHR systems that can seamlessly exchange health
information to improve patient care and, ultimately, population health outcomes.1 The ONC and CMS
have laid the foundation for the rapid and systematic adoption of EHR systems by healthcare systems
and providers across the United States through two sets of regulations, the ONCs EHR Standards and
Certification Criteria2 and the Medicare and Medicaid EHR Incentive Program.3 The ONC and CMS
regulations work together and are progressive, meaning the standards and certification requirements
and clinical quality measures are related and increase with each stage of implementation. The
certification criteria establish the technical specifications that EHR systems must comply with to
be certified in order for eligible providers and hospitals to participate in the incentive program.
The incentive program promotes adoption of EHRs and the meaningful use of health information
technology (IT) by providing payments to eligible healthcare providers and hospitals that demonstrate
1 Healthcare providers and consumers have the potential for greater access to health information through investments in EHRs and a focus on their meaningful use, as
described by the Health Information Technology for Economic and Clinical Health (HITECH) Act, as enacted by the American Recovery and Reinvestment Act of 2009.
2 ONCs Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology;
Final Rule (45 CFR 170, Stage 1) and Health Information Technology: Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record
Technology, 2014 Edition; (45 CFR 170, Stage 2). Retrieved from http://www.gpo.gov/fdsys/pkg/FR-2010-07-28/pdf/2010-17210.pdf and
http://www.gpo.gov/fdsys/pkg/FR-2012-09-04/pdf/2012-20982.pdf
3 Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Final Rule (42 CFR Parts 412, 413, 422 et al, Stage 1) and Medicare and Medicaid
Programs; Electronic Health Record Incentive ProgramStage 2 (42 CFR Parts 412, 413, and 495). Retrieved from
http://www.gpo.gov/fdsys/pkg/FR-2010-07-28/pdf/2010-17207.pdf and http://www.gpo.gov/fdsys/pkg/FR-2012-09-04/pdf/2012-21050.pdf

The Essential Role of Laboratory Professionals

Ensuring the Safety and Effectiveness of Laboratory Data in Electronic Health Record Systems

achievement with established EHR clinical quality measures.4 The objective is to implement EHRs
in three stages over a multi-year period, focusing on 1) data capture and sharing (infrastructure), 2)
advanced clinical processes (health information exchange), and 3) improved outcomes (advanced
use of data), in 2012, 2014 and 2017, respectively. The actual years of implementation for Stage 2
and Stage 3 may be subject to change if determined appropriate by the U.S. Department of Health
and Human Services (HHS), based upon ongoing evaluation of the progress and success of EHR
implementation.

Institute of Medicine (IOM)

As the percentage of providers using EHR systems has significantly increased over the last decade,5
there is concern that EHR system-related patient safety events may also be on the rise. The November
2011 Institute of Medicine report, Health IT and Patient Safety: Building Safer Systems for Better Care,
noted that the lack of empirical data on the nature and prevalence of EHR system-related adverse
patient events makes it challenging to determine the extent of the associated risks to patient
safety.6 However, several patient safety events related to the use of laboratory data in EHR systems
are identified in the Food and Drug Administrations (FDA) Manufacturer and User Facility Device
Experience (MAUDE) database.7 This database includes mandatory (for death or serious injury) and
voluntary adverse event reports involving medical devices, including events associated with EHR
systems. One of these patient safety events is described in this paper to illustrate reported safety
concerns.

Clinical Laboratory Improvement Advisory Committee (CLIAC) and the

Communication in Informatics Workgroup
In response to concerns and questions raised by members of the Clinical Laboratory Improvement
Advisory Committee (CLIAC, an HHS-Federal Advisory Committee) about the extent of the challenges
with the usability and interoperability of laboratory data in EHR systems, the Laboratory Science
Policy and Practice Program Office,8 Centers for Disease Control and Prevention (CDC), convened the
Communication in Informatics Workgroup (CIIWG) in July 2012. This group included experts9 in the
fields of health informatics, laboratory science, and medical practice. Group members shared their
individual experiences with laboratory data-related health IT challenges and described potential
patient safety issues that should be addressed. A preliminary report from the CIIWG was presented

4 For the Meaningful Use objective to incorporate clinical lab test results into the EHR as structured data, an example of a CMS EHR performance measure
implemented in Stage 1 (2012) is as follows: More than 40% of all clinical lab test results ordered by the EP, or an authorized provider of the eligible hospital or CAH, for
patients admitted during the EHR reporting period whose results are either in a positive/negative or numerical format are incorporated in certified EHR technology as
structured data. Retrieved from http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/downloads/2_Clinical_Lab_Test_Results.pdf
5 Hsiao, C. J., & Hing, E. (2012). Use and characteristics of electronic health record systems among office-based physician practices: United States, 20012012. NCHS
Data Brief, 111. Retrieved from http://www.cdc.gov/nchs/data/databriefs/db111.htm
6 Institute of Medicine (2012). Health IT and Patient Safety: Building Safer Systems for Better Care. The National Academies Press. The ONC commissioned the IOM
to establish a committee to explore how health IT assisted care could be made safer so that the potential benefits of Health IT could be realized. This report is a result of
that request. Retrieved from http://www.nap.edu/catalog.php?record_id=13269
7

FDA MAUDE - Manufacturer and User Facility Device Experience. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Search.cfm

8 The Laboratory Science Policy and Practice Program Office at CDC has been renamed The Division of Laboratory Programs, Standards and Services at the time of
publishing this paper.
9

The Communication in Informatics Workgroup was convened by CDCs Division of Laboratory Science and Standards in Atlanta, GA on July 1112, 2012.

Centers for Disease Control and Prevention

to the CLIAC in August 2012.10 The results of the CIIWG report prompted the CLIAC to send a letter
to the Secretary of the Department of Health and Human Services in September 2012 highlighting
the potential for serious risks to patient safety in the implementation of EHR systems and offered
several high level recommendations to mitigate risks.11 Based upon the CLIAC recommendations and
the CIIWG report, the Division of Laboratory Programs, Standards and Services, now in the Center for
Surveillance, Epidemiology and Laboratory Services, decided to develop this white paper.

Patient Safety Organizations (PSOs)

Patient Safety Organizations (PSOs) are also identifying patterns of safety concerns associated with the
adoption of health IT.12 For example, ECRI Institutes (formerly the Emergency Care Research Institute)
Top 10 Health Technology Hazards for 2013 includes four hazards associated with the adoption of
health IT.13 This is a fourfold increase over the one hazard identified by ECRIs Top 10 list for 2012.14
In addition, the January 2013 report entitled ECRI Institute PSO Deep Dive on Health Information
Technology, indicates that for health IT (or EHR) associated events, laboratory information systems
ranked as the fourth most implicated health IT system, representing 22 of the total 171 (13%) events
reported by 36 healthcare facilities over a nine week period.15 Examples identified by ECRI of problem
areas across all health IT systems in the report included: inadequate data transfer from one health IT
system to another; data entry in the wrong patient record; incorrect data entry in the patient record;
failure of the health IT system to function as intended; and configuration of the system in a way that
can lead to mistakes. Recognizing that such errors can occur without health IT systems, there is cause
for concern as an occasional error in a health IT system can be replicated very quickly across a large
number of patients. Combining documented patient safety events with the anecdotal evidence shared
by individual laboratory professionals across the U.S. presents enough concern to warrant further
investigation and mitigation.16

10 Clinical Laboratory Improvement Advisory Committee (CLIAC), Report on Communication in Informatics Workgroup, CLIAC August 2012 Meeting Summary. See
Presentations and Committee Discussion: Report on Communication in Informatics Workgroup. Retrieved from http://wwwn.cdc.gov/CLIAC/Meetings/PastMeetings.aspx
11 Clinical Laboratory Improvement Advisory Committee (CLIAC) (2012, September 26). 2012 Letter from CLIAC to HHS Secretary regarding Electronic Health Records.
Retrieved from http://wwwn.cdc.gov/cliac/pdf/2012_Oct_CLIAC_%20to_Secretary_re_EHR.pdf
12 PSOs are part of a national system for providers to voluntarily report medical errors, near misses, and other patient safety events while having assurance that the
information will be protected from legal discovery and kept confidential.
13 ECRI Institute (2012, November). ECRI Institute 2013 Top 10 Health Technology Hazards. ECRI Institute. Retrieved from http://www.ecri.org/2013hazards. See
hazards 4, 5, 7, and 9.
14 ECRI Institute (2011, November). ECRI Institute 2012 Top 10 Health Technology Hazards. ECRI Institute. Retrieved from http://www.ecri.org/2012_Top_10_Hazards.
See hazard 5.
15

ECRI Institute (2013, January). ECRI Institute PSO Deep Dive: Health Information Technology. ECRI Institute.

16

Communication in Informatics Workgroup (CIIWG) meeting, Centers for Disease Control and Prevention, July 1112, 2012.

The Essential Role of Laboratory Professionals

Ensuring the Safety and Effectiveness of Laboratory Data in Electronic Health Record Systems

WHITE PAPER
AND FOCUS AREAS FOR ACTION
The concerns for potential and real patient harm as shared by individual experts, CLIAC, and
PSOs prompted CDC to develop this white paper identifying examples of patient safety risks and
highlighting how laboratory professionals expertise can contribute to the development of safer EHR
systems. This paper proposes three focus areas where laboratory professionals can contribute their
expertise to the improvement of EHR system design, development, and implementation to address
laboratory data-related patient safety concerns. These strategies were developed based upon the
input received from the members of the Communication in Informatics Workgroup:
1. Engagement: Laboratory professionals can provide laboratory expertise for health IT
decision-making in the design, development, and implementation of EHR systems at both
national and local levels;
2. Data Integrity and Usability: Laboratory professionals can guide and maintain data integrity
and usability to ensure that laboratory data are accurately presented in the EHR and available
at the point of care; and
3. Innovation: Laboratory professionals can partner with stakeholders to stimulate innovation
in EHR technology and usability to reduce laboratory data-related errors attributed to the use
of EHR systems.
These focus areas are described in further detail below.

#1 Engagement
Laboratory professionals can provide laboratory expertise for
health IT decision-making in the design, development, and
implementation of EHR systems at both national and local levels.
The intersection of laboratory information management, compliance with laboratory regulations, and
the usability of laboratory data within EHR systems is extremely complex. Resolving EHR system issues
requires collaboration and significant human and capital investment by professional organizations,
regulators, and the health IT industry to ensure the integrity and proper use of laboratory data across
the spectrum of patient care settings. Health information system developers and implementers need
to understand laboratory information management, exchange, stewardship, and display requirements.
Expert consultation with laboratory professionals, as well as clinicians who use laboratory data, is
critical to bridging the knowledge gap between clinical practice and EHR system technology design
and implementation.
For the reasons cited above, the inclusion of laboratory professional expertise in national health
IT policy and standards development is an important factor in ensuring laboratory data are well
managed and compliant, and in improving the usability of EHR systems for the benefit of patient care.
When developing and implementing health IT policies and standards, it is necessary to engage those
who use EHR systems to fully understand the potential patient safety consequences. For laboratory

Centers for Disease Control and Prevention

data, these users include both clinicians and laboratory professionals. The active participation of
laboratory professionals as part of multidisciplinary teams is essential to improving the safety of
EHR systems by identifying and eliminating laboratory data exchange and display errors, as well
as supporting compliance with existing and new federal regulations. Laboratory professional
organizations can communicate with federal agencies developing policy, certification, and
standards, such as ONC and the National Institute of Standards and Technology (NIST) to determine
opportunities and mechanisms for their members to get involved in collaborative, multidisciplinary
efforts. Healthcare executives and laboratory leaders can also encourage and support the participation
of laboratory professionals in the development of national health IT policies and standards.
Participation by laboratory professionals in the development of institutional health IT policies and
standards also helps to ensure that patient safety concerns related to laboratory data are considered
and addressed at the local level. Laboratory professional input is important since each organizations
circumstances and technologies are unique and vary by clinical setting, such as those seen in a
private practice, hospital, or healthcare system. Executive and medical leadership at these institutions
can develop a multidisciplinary team, including pathologists and other laboratory professionals, to
provide their expertise in the development of such policies and evaluate their potential impact on
patient care and outcomes. Laboratory professionals serving on such teams can consider whether
their institutions unique needs are appropriately addressed in the development of these local policies.
During the implementation of an EHR system or any clinical decision support technology, these teams
can use standardized resources to assess its safety and functionality, such as the ONC funded Safety
Assurance Factors for EHR Resilience (SAFER) Guides.17,18 The combination of seeking consultation from
a multidisciplinary team and using standardized EHR assessment tools will provide tailored advice to
healthcare executives on their organizations specific scope of issues throughout the configuration,
implementation, use, and evaluation of health IT systems.
Addressing safety concerns related to laboratory data in EHR systems for rural hospitals and
community health centers will be particularly challenging because of limited access to health IT
expertise and other infrastructural needs. Such health institutions can benefit from existing programs
that allow the sharing of expertise, lessons learned, and benchmarks from healthcare settings across
the nation. Existing resources are available that support the improvement and use of laboratory health
IT, but laboratory professionals may not be aware of these resources. For example, the Laboratory
Interoperability Collaberative provides support to hospital laboratories with the technical aspects
of EHR system implementation and complying with Meaningful Use requirements.19 Regenstrief
Institute, Inc. offers a free mapping tool for converting local laboratory coding to LOINC.20,21 To raise the
awareness of these and other available resources, professional societies and federal health agencies,
17 The Office of the National Coordinator for Health Information Technology (2012, December 21). Health Information Technology Patient Safety Action & Surveillance
Plan for Public Comment. HealthIT.gov. Retrieved from http://www.healthit.gov/sites/default/files/safetyplanhhspubliccomment.pdf. The SAFER Guides were referenced
in the ONCs December 2012 Health Information Technology Patient Safety Action and Surveillance Plan released for public comment and are likely to fill an immediate
need for such an assessment.
18 Singh, H., Ash, J., Sittig, D. (2013) Safety Assurance Factors for Electronic Health Record Resilience (SAFER): study protocol. BMC Med Inform Decis Mak. 2013; 13: 46.
Published online 2013 April 12. doi: 10.1186/1472-6947-13-46. Retrieved from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3639028/
19 Laboratory Interoperability Collaborative (LIC). Retrieved from http://www.labinteroperabilitycollaborative.org
20 LOINC Mapping Assistant (RELMA). LOINC from Regenstrief. Retrieved from http://loinc.org
21 The use of any product names, trade names, images, or commercial sources is for identification purposes only, and does not imply endorsement by the U.S.
Department of Health and Human Services.

The Essential Role of Laboratory Professionals

Ensuring the Safety and Effectiveness of Laboratory Data in Electronic Health Record Systems

such as CMS, FDA, and CDC, can collaboratively develop strategies that will connect laboratories and
providers in rural and community health centers with available resources.
The list below summarizes actionable engagement strategies that can be implemented by
laboratory professionals.

Engagement Strategies
Laboratory Professionals and Organizations can:
Provide laboratory expertise for health IT decision making at national
and local levels,
Serve on policy and standards federal advisory committees and the
numerous workgroups that support the ONC healthcare initiatives,
Monitor and submit comments on proposed rules and guidelines
from all areas of government that impact EHR implementation and
future EHR data use, including those from ONC, CMS, FDA, NQF, NIST,
and AHRQ,22
Foster healthcare executive and laboratory leadership support
for staff to participate in national collaborative efforts such as
ONCs Standards & Interoperability Framework workgroups and
other initiatives,
Work with ONC, NIST, and the Healthcare Information and
Management Systems Society (HIMSS) and other policy, certification,
and standards development organizations to determine opportunities
for collaboration.
Institute communication networks for the timely distribution of
relevant healthcare information and issues, and
Improve awareness of and connect providers and laboratories with
resources that support the improvement and use of EHR systems.

22 National Quality Forum (NQF), National Institute of Standards and Technology (NIST), and Agency for Healthcare Research and Quality (AHRQ).

Centers for Disease Control and Prevention

#2 Data and Usability

Laboratory professionals can guide and maintain data integrity and
usability to ensure that laboratory data are accurately presented in
the EHR and available at the point of care.
Like all medical information, laboratory orders and results contained in EHRs convey information
that is inherently private, confidential, and sensitive for patients, their families, and healthcare
providers. Patient-specific laboratory data are integral to accurate diagnosis, appropriate treatment,
and determining overall patient care decisions. Therefore, assurance is needed that patient-specific
laboratory information is provided in a timely manner to the intended recipient, not altered in an
exchange between systems (interoperability and fidelity), and displayed in a manner assuring
accurate interpretation.
The graphic below shows how laboratory data and other health information can be exchanged with
numerous recipients throughout the healthcare system. Laboratory professionals, clinicians, patients,
and other stakeholders must be able to trust that the EHR system provides accurate, reliable, and
timely information. When this trust is not proven through vigorous usability testing, the resultant
patient safety risks can range from negligible to potentially catastrophic. The stories on the following
pages illustrate how these consequences can manifest in patient harm.

Health Information Exchange in the Healthcare System

The Essential Role of Laboratory Professionals

Ensuring the Safety and Effectiveness of Laboratory Data in Electronic Health Record Systems

Unconventional Results Display

Delayed Diagnosis and Treatment
A young womans abnormal Pap smear results went
undetected for four years due to a usability issue with her
physicians EHR system.23 Due to a default setting, the system
presented the physician with the patients previously normal
laboratory result and the most recent abnormal result went
unnoticed. The young womans advanced cervical cancer was
only detected when she sought treatment for other symptoms
that had developed. As a result of the delay in diagnosis and
treatment, the young woman had a hysterectomy.
The EHR systems usability challenge described above was not the sole factor
contributing to the sub-optimal care of the patient, but the one that illustrates
the need for thorough usability testing when designing, configuring and implementing EHR systems
to assure optimized display behavior. Laboratory professionals have specialized knowledge about the
test results they generate and the content necessary to inform clinical decisions, and their expertise is
critical to developing laboratory data scenarios for usability testing. Laboratory expertise is also needed
during the implementation of the EHR system within each organization, such as the physicians office in
the example above, to verify that laboratory data are successfully transmitted and accurately displayed
on the physicians user-screens. Design, configuration and implementation of an EHR system should
include a user-centered assessment of how the new technology will affect existing clinical workflow,
and appropriate EHR configuration or workflow modifications being made prior to full implementation.
This will ensure that critical steps, such as follow-up for abnormal results are not missed.

23 Singer, S. (2010, June 5). Electronic medical records may cause patient care errors, Florida medical board says. Palm Beach Post [Ft. Lauderdale]. Retrieved from
http://www.palmbeachpost.com/news/news/electronic-medical-records-may-cause-patient-care-/nL7Yc/

10

Centers for Disease Control and Prevention

Unexpected Interpretation of Daily

Delayed Testing Contributes to Serious
Anticoagulant Therapy Risk
The patient story below illustrates how usability errors when ordering a
Prothrombin Time/International Normalized Ratio (PT/INR) led to serious
patient risk.

A patient being treated with the anticoagulant warfarin was

admitted to the hospital.24 In order to monitor the patients
warfarin dose, a daily PT/INR test was ordered via the EHR
system. Unknown to the clinicians, the EHR system had been
programmed to interpret a daily draw time at a different
time of day than expected. Instead of drawing blood for the
test at 6 AM, which was the expected meaning of daily, the
blood would be drawn at 4 PM.
When the patients PT/INR value was checked via the EHR system the next day,
there was no PT/INR result for that morning nor was there an indication that
an order for a PT/INR test was pending. Assuming the PT/INR test had not been
ordered, the clinician gave the regularly prescribed dose of warfarin to the patient
and reordered the PT/INR test. Later that afternoon, the original daily PT/INR order
was drawn and the test results indicated a dangerously elevated PT/INR value
indicating a bleeding risk. Once this information was known, the care team was
able to adjust the medication dose, lowering the PT/INR. The patient experienced
no further symptoms.
Had the patients PT/INR been performed at the time expected by the ordering
clinician, the risk for potentially serious complications associated with excessive
warfarin dosing could have been prevented.
The clinician who reported the particular PT/INR incident described above noted that the computer
transformed daily into an oddball time and that the average [user] screensare poorly usable due to
deficient format and too many lines of clinically useless information.25 The usability of EHR system user
screens can also contribute to the safety and effectiveness of clinical decision-making and patient care.
In this example, there are two usability issues. First, the EHR system was configured with a definition
for daily that did not match the expectation of the ordering clinician. Second, the content of the user
24

MAUDE Adverse Event Report. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.cfm?MDRFOI__ID=1840232

25 Ibid.

The Essential Role of Laboratory Professionals

Ensuring the Safety and Effectiveness of Laboratory Data in Electronic Health Record Systems

11

screen was cluttered. Both issues indicate that there may have been incomplete usability testing and a
limited user-centered workflow assessment during configuration and implementation to ensure that
the EHR system would support clinical practice expectations.
Patients who rely on laboratory testing to monitor their medication therapy may be particularly
vulnerable to errors associated with the interpretation of laboratory orders or results, making even a
seemingly minor error potentially life-threatening. The patient case above is one of eight laboratoryrelated EHR events included in the FDAs MAUDE database at the time of review for this paper. While
more data are needed to identify trends and draw specific conclusions, three of the eight reported
events (37.5%) were related to anticoagulation therapy. Considering previously documented
information on the serious and potentially fatal consequences of PT/INR related incidents, 26 and
extrapolating that only a small fraction of EHR incidents are voluntarily reported to the FDA, the
percentage is a cause for concern. As stated previously, laboratory professionals have the expertise to
assess the usability of EHR system ordering and reporting functions, and should give extra attention to
concerns related to high-risk patient testing such as the PT/INR.

Opportunities for Laboratory Professionals to Improve Data Integrity

and Usability
Organizations like the ONC, NIST, and HIMSS convene multidisciplinary groups to develop guides27,28
and other resources to improve the usability, interoperability, and safety of EHR systems. To assess
usability during EHR configuration and implementation, the ONC is investing in the development
of a series of Safety Assurance Factors for EHR Resilience (SAFER) Guides, mentioned previously. These
guides, published in January 2014, will assist healthcare providers in assessing the patient safety
risks of the ordering and laboratory test result reporting functions in their EHR and other health IT
systems.29 The expertise of laboratory professionals is needed in such assessment efforts to ensure the
accuracy and usability of laboratory data in EHR systems.
There are also existing examples of how laboratory professionals are providing their expertise to
improve the safety and effectiveness of health IT. A variety of public and private stakeholders with
laboratory expertise are currently serving on the ONCs the Laboratory Report Tiger Team and the
Standards and Interoperability (S&I) Framework.30 The Laboratory Report Tiger Team is tasked with
making recommendations to ONC that will reduce the cost and burden associated with implementing
EHR system interfaces that support laboratory test ordering and results reporting to physician offices.
The Laboratory Tiger Team has compiled a list of issues limiting the interoperability and display of
laboratory test results in EHR systems. Some examples are provided on the following page.

26 Public Health Dispatch: Adverse Events and Deaths Associated With Laboratory Errors at a Hospital, Pennsylvania, 2001. Centers for Disease Control and Prevention.
Retrieved from http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5033a4.htm
27 Lowry, S. Z., Quinn, M. T., & Ramaiah, M. (2012). A Human Factors Guide to Enhance EHR Usability of Critical User Interactions when Supporting Pediatric Patient
Care. NIST Interagency/Internal Report (NISTIR) - 7865, 46 pp. doi:10.6028/NIST.IR.7865
28 Osheroff, J. A., Teich, J. M., Levick, D., & Et al. (2012). Improving Outcomes with Clinical Decision Support: An Implementers Guide (2nd ed.). US: Healthcare
Information and Management Systems Society. Retrieved from http://www.nist.gov/customcf/get_pdf.cfm?pub_id=911520
29

See the SAFER Guides published on the ONCs website (January 2014): http://www.healthit.gov/policy-researchers-implementers/safer

30 The ONCs Standards & Interoperability (S&I) Framework website: http://www.siframework.org/

12

Centers for Disease Control and Prevention

Examples of EHR Interoperability and Display Issues

Hard-coding of data elements in the EHR system, such as reference
ranges and units of measure, which can cause errors when the
reporting laboratory does not use the same values;
Truncation of text and long number strings causing incompleteness
of data when the laboratory and EHR system have different maximum
character limits for fields;
Chronological versus reverse chronological display of test results
causing the most recent reports to display at the end rather than the
beginning of a user screen;
Allowable special characters (e.g., #, &, $) causing unusual system
behaviors, such as displaying gibberish or stopping interface
communications;
Inconsistencies in design of alerts, flags, and color-coding between
systems causing user confusion; and
Inconsistencies between the printed version of laboratory reports
and the user-screen display causing user confusion.
The Standards & Interoperability (S&I) Framework is a collaborative community of volunteer
participants from the public and private sectors who are focused on providing the tools, services
and guidance to facilitate the functional exchange of health information. Examples include technical
implementation guides for computer interfaces. Recommendations from the Tiger Team have created
additional S&I Framework workgroups to address the specific standards needed for laboratory data
exchange. A functional behaviors guide for Laboratory Orders and Results Interfaces is currently
under development and volunteers are being solicited for a second initiative to create an agreed upon
set of laboratory order codes, named the a LOINC Order Code Project.31 Laboratory professionals
knowledgeable in any key area, including laboratory operations, CLIA or accreditor requirements, or
health IT standards, are desirable volunteers for participating on an S&I Framework workgroup.
EHR systems provide significant advantages for managing laboratory information as structured
data compared to paper records or electronic versions of paper records. The use of structured
data substantially improves accessibility and portability of health information, local and national
surveillance programs, and clinical decision support tools. Thus, it is important for laboratory and
other healthcare professionals to invest their time and effort now in the development of consensus
based information exchange standards. Existing unintended system and display behaviors such as
those listed above need to be resolved to fully realize the benefits of EHR systems. To further promote
user-centered design features that support clinical practice and workflows, specific laboratory data
usability guidance and related resources are needed. Laboratory professionals can seek out and
create opportunities to collaborate with other stakeholders to develop guides and practice models to
improve EHR systems and Clinical Decision Support (CDS) tools.

31

a LOINC Order Code Project on the S&I Framework Wiki: http://wiki.siframework.org/a+LOINC+Order+Code+Join+the+Initiative

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The need to support development of health IT for laboratory data has been recognized by several
professional organizations and the CDC. The College of American Pathologists published a white
paper with guidance for laboratory leaders regarding laboratory information system interfaces
with EHRs.32 The Association for Pathology Informatics (API) also published a white paper with a
companion toolkit for assessing functionality of laboratory information systems, enabling meaningful
comparisons between different systems when purchasing decisions are being made.33 APHL has
also published a laboratory informatics self-assessment guide for public health laboratories which
is equally applicable to clinical laboratories.34 An online resource for coding includes the Laboratory
Interoperability Collaborative, which was developed by the American Hospital Association and the
College of American Pathologists under a grant from the CDC.35
The list below summarizes actionable data integrity and usability strategies that can be
implemented by laboratory professionals.

Data Integrity and Usability Strategies

Laboratory Professionals and Organizations can:
Engage with EHR developers on the development and design of
laboratory-related EHR system features, such as critical results alerts,
Provide laboratory expertise for assessing and improving the
interoperability and usability of EHR systems at both organizational
and national36 levels, and
Facilitate rigorous assessment of the usability of laboratory test ordering
and reporting functions in the EHR for high-risk patient testing.

#3 Innovation
Laboratory professionals can partner with stakeholders to
stimulate innovation in EHR technology and usability to reduce
laboratory data-related errors attributed to the use of EHR systems.
There is a critical need for innovation to improve the usability of EHR systems and benefit patient
outcomes. The ONCs EHR certification criteria establish ground level requirements, providing developers
the foundation for new and innovative health IT systems. With an infusion of workflow engineering and
creative vision in the design and development of health IT, there is an opportunity to bring the future
promise of sophisticated analytics into todays healthcare system. Such inventiveness could reduce
delays in treatment and potentially save lives, as demonstrated by the following patient scenario.
32 Laboratory Interoperability Best Practices, The College of American Pathologists. Retrieved from
http://www.cap.org/apps/docs/committees/informatics/cap_dihit_lab_interop_final_march_2013.pdf
33 A Methodology for Assessing Functionality and Enabling Comparisons Among Competing Systems, Association for Pathology Informatics. Retrieved from
http://www.pathologyinformatics.org/toolkit
34 Laboratory Efficiencies Initiative Informatics Self-Assessment Tool, CDC. Retrieved from
http://www.aphl.org/aphlprograms/lss/Laboratory-Efficiencies-Initiative/Pages/Informatics.aspx
35 The Laboratory Interoperability Collaborative. Retrieved from http://labinteroperabilitycollaborative.org/index.php
36 National, voluntary participation opportunities include development of health information exchange standards on the ONCs Standards & Interoperability (S&I)
Framework: http://www.siframework.org/

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Centers for Disease Control and Prevention

Innovation Needed for Earlier Detection of

Emergent Conditions
A 10-year old girl presented to the emergency department
with vomiting, fever and an elevated pulse rate. She also had
multiple bug bites on her legs, some of which were red and
swollen from scratching. Based on her symptoms, doctors
diagnosed her with the flu and she was sent home. Two hours
after she was discharged, her laboratory results revealed
an elevated white blood cell count (WBC). This additional
information indicated the need to promptly rule out a serious
bacterial infection. However, the laboratory result was not
reviewed in conjunction with the girls clinical findings.
The girls condition worsened and she returned to the
emergency department the next day. She was admitted to the ICU with severe
multiple system organ failure, placed on IV antibiotics and died shortly thereafter
from septic shock and staphylococcal bacteremia.
This patient story illustrates the opportunity and critical need for innovation in health IT. Innovative
clinical decision support (CDS) tools can be created to analyze patient records automatically when
new information is received in the EHR, such as the elevated WBC in this example. If such CDS tools
existed, the reduction in time to diagnosis and treatment for an acute condition could be life-saving.
Emergent conditions like sepsis can be detected earlier, prompting clinicians to further evaluate the
patient. A UC Davis study performed on retrospective aggregate patient data also concluded that
patients at risk for sepsis could be identified for prompt treatment through computerized analysis of
clinical indicators.37
Innovation in EHR system test result management functionality could also make an immediate
impact on patient safety. Some EHR systems include an alert feature to notify physicians of different
types of critical situations that require management or immediate attention. When functioning
appropriately, these alerts can support the timely interpretation of laboratory test results, which
leads to timely diagnosis and treatment of conditions. When there are too many alerts (alert fatigue),
or when the alerts do not provide meaningful information, the alerts may have the opposite effect.
The implications of electronic test result management tools, like alerts, are just beginning to be
understood.38 A recent study found that current capabilities for test result management are not yet
adequate and that new EHR system features will need to be designed and developed to address
patient safety issues.39

37 Gultepe E, et al. J Am Med Inform Assoc 2014;21:315325. doi:10.1136/amiajnl-2013-001815

38 Singh, H., Spitzmueller, C., Peterson, N. J., & Et al. (2012). Primary care practitioners views on test result. J Am Med Inform Assoc. doi:10.1136/amiajnl-2012-001267.
Retrieved from http://jamia.bmj.com/content/early/2012/12/24/amiajnl-2012-001267.full.pdf
39 Ibid
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Ensuring the Safety and Effectiveness of Laboratory Data in Electronic Health Record Systems

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Laboratory professionals and other stakeholders can consider being more intentional in supporting
the advanced use of information and innovation now so that future EHR systems have intelligent
features to help clinicians promptly identify emergent conditions and save lives. A forum for
collaboration could be a key strategy to help. This forum could take the form of a national
collaboration panel including laboratory professionals, human-factors engineers,40 health IT
designers, informaticians, clinicians, and EHR system users. Laboratory professional organizations can
champion collaborative efforts and support research agendas that will provide more detail on the
issues surrounding the use of laboratory data in EHR systems, eliminating barriers to the free-flow
of information on patient safety risks and EHR system-related errors. Such collaboration could lead
to stimulating innovative ways to display laboratory and other data so that the right information is
available at the right time and in the right format.
Innovations in health IT are needed now. To enable collaboration, access to data on EHR systemrelated usability and interoperability errors is needed. More information can help stakeholders
understand the scope and context of these errors in relation to patient safety and propose solutions.
Unfortunately, there are barriers to the free flow of information regarding EHR system-related errors
and related patient safety risks. Non-disclosure agreements and other similar practices of the health IT
industry prevent sharing of information on patient safety risks for certain EHR systems.41 Efforts by the
Agency for Healthcare Research and Quality (AHRQ) are currently underway to provide a mechanism
for reporting these adverse events related to use of the EHR, but no current forum exists where all
stakeholders can collectively learn from the errors of their colleagues systems.42
Legal barriers and the lack of aggregate data on EHR system-related patient safety events limit
understanding of the scope and context of errors in EHR systems which, in turn, can limit or delay
innovation. More data on real and potential EHR system-related errors are needed from credible,
vetted sources to support assessment of EHR systems, identify patterns of safety concerns, and make
improvements. In the interim, professional laboratory organizations could encourage laboratories
to participate in the assessment of EHR systems and to voluntarily report issues to PSOs that offer
confidentiality and legal protection.43
Patients also increasingly expect a viable method to access their medical information in a timely,
reliable, secure, and private manner. This demand is likely to increase with implementation of the
Patient Access rule, amending CLIA and the Health Insurance Portability and Accountability Act of
1996 (HIPAA) Privacy Rule to provide patients access to their test reports. Laboratory professionals can
help lead the effort to innovative patient access to laboratory information and can produce guidelines
for the design of patient portals. Patients would also benefit from resource materials that would help
to educate and inform their healthcare decision-making. Laboratory professionals can partner with
40 Human factors engineering is defined by the Agency for Healthcare Research and Qualitys Patient Safety Network as the discipline that takes into account
human strengths and limitations in the design of interactive systems that involve people, tools and technology, and work environments to ensure safety, effectiveness,
and ease of use. Retrieved from http://psnet.ahrq.gov/primer.aspx?primerID=20
41 Roth, J. H. (2011). Regulating Your Medical History Without Regulations: A Private Regulatory Framework To Electronic Health Record Adoption. Boston University
Law Review, 91(6), 2103-2129. Retrieved from http://www.bu.edu/law/central /jd/organizations/journals/bulr/volume91n6/documents/ROTH.pdf
42

IOM, 6.

43 Middleton, B., Bloomrosen, M., Dente, M. A., Hashmat, B., & Et al (2012). Enhancing patient safety and quality of care by improving the usability of electronic health
record systems: recommendations from AMIA. Am Med Inform Assoc. 2013;20(e1):e28. doi:10.1136/amiajnl-2012-001458. Retrieved from
http://jamia.bmj.com/content/20/e1/e2. See recommendation 4b.

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Centers for Disease Control and Prevention

stakeholders and stimulate innovation by convening experts and developing guidelines for improved
patient access to laboratory data.44 Laboratory professionals can help lead the effort to innovative
patient access to laboratory information and can produce guidelines for the design of patient portals.
Patients would also benefit from resource materials that educate and inform their healthcare decisionmaking. Laboratory professionals can partner with stakeholders and stimulate innovation by convening
experts, eliminating barriers to the free-flow of information on EHR system-related errors and patient
safety risks, and developing guidelines for improved patient access to laboratory data.
The list below summarizes actionable innovation strategies that can be implemented by
laboratory professionals.

Innovation Strategies
Laboratory Professionals and Organizations can:
Champion collaborative efforts and support research agendas
to provide more detail on laboratory data-related patient safety
concerns in the EHR,
Collaborate with human factors engineers, EHR system interface
designers, and others to advance innovation and the usability of
laboratory data displays,
Encourage participation in EHR system assessments and voluntary
reporting of EHR-related issues to PSOs, and
Lead innovation in patient access to laboratory information.

44 44: CLIA Program and HIPAA Privacy Rule; Patients Access to Test Reports Final Rule (79 FR 7289):
http://www.gpo.gov/fdsys/pkg/FR-2014-02-06/pdf/2014-02280.pdf

The Essential Role of Laboratory Professionals

Ensuring the Safety and Effectiveness of Laboratory Data in Electronic Health Record Systems

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SUMMARY
In this early stage of EHR system adoption, laboratory professionals have a unique opportunity to help
create health IT systems that enable optimized healthcare decision making, improve the timeliness,
consistency and quality of care, add value for providers and patients, and save lives. This paper
proposes that laboratory professional organizations and laboratory professionals focus their efforts on
the following to benefit the development of a health IT infrastructure and ensure the safe and effective
use of laboratory information in EHR systems:
1. Engagement: Laboratory professionals can provide laboratory expertise for health IT
decision-making in the design, development, and implementation of EHR systems at both
national and local levels;
2. Data Integrity and Usability: Laboratory professionals can guide and maintain data integrity
and usability to ensure that laboratory data are accurately presented in the EHR and available
at the point of care; and
3. Innovation: Laboratory professionals can partner with stakeholders to stimulate innovation in
EHR technology and usability to reduce laboratory data-related errors attributed to the use of
EHR systems.
The U.S. healthcare system is transforming at an unprecedented pace with renewed focus on patient
wellness, disease prevention, and provider accountability. This transformation is being facilitated by
the rapid expansion of health IT, which is bringing new challenges and opportunities for providers
and patients with the interpretation and use of laboratory information. Our nations patients are also
our families, friends and loved ones. They deserve our professional commitment to the thoughtful
design of and innovation in health IT systems to achieve the future vision and full intent of Meaningful
Use. The absence of clinical input in the development and implementation of health IT can produce
unintended consequences and jeopardize patient safety.

CONCLUSION
Participation and collaboration are key. National agencies can work together and build consensus on
the patient safety priorities.45 Laboratory professionals and organizations can support the future vision
and help improve the overall quality of healthcare for individual patients and the national population.
To do so, laboratory professionals can educate themselves on the promises and pitfalls of EHR systems,
and proactively engage in creating the solutions essential to sustaining the transformation of the U.S.
healthcare system. In the best case scenario, the laboratory profession, laboratory industry, clinicians,
and governmental agencies would work together to create and promote the implementation of
standards, policies, practices, and services that improve the use of laboratory information throughout
the patient encounter.
Understanding and integrating the expertise and perspective of laboratory professionals in the
development of EHR systems is critical to ensuring the safety and effectiveness of laboratory data in
EHR systems and establishing a solid foundation for a health IT infrastructure to benefit this nations
citizens now and for future generations.
45 Sittig, Dean F., Singh, H. (2012). Electronic Health Records and National Patient-Safety Goals. N Engl J Med. doi: 10.1056/NEJMsb1205420. Retrieved online May
2014: http://www.nejm.org/doi/full/10.1056/NEJMsb1205420

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This white paper was authored by the Laboratory Health Information Technology (LabHIT) Team of the Division of Laboratory Programs,
Standards and Services in the Office of Public Health Scientific Services, Centers for Disease Control and Prevention (CDC),
U.S. Department of Health and Human Services, Atlanta, GA 30333. The LabHIT Team can be contacted at LabHIT@cdc.gov.

CDC LabHIT Team

Megan E. Sawchuk, MT(ASCP)

Nancy E. Cornish, MD, FCAP

MariBeth Gagnon, MS, CT(ASCP)HTL

Millie L. Linville, BS

Anne Pollock, MT(ASCP)

John F. Stinn, MA

Ira M. Lubin, PhD, FACMG

The findings and conclusions in this white paper are those of the authors and do not necessarily represent the views of the CDC.
The authors would like to thank the members of the Communication in Informatics Workgroup and additional white paper
reviewers for sharing their individual experiences and perspectives during the development of this paper.

Communication in Informatics Workgroup

Joanna C. Baker, MSPH, MT (ASCP)
Laboratory Information Officer
Moncrief Army Community Laboratory, Fort Jackson, SC

Cynthia Johns, MSA, MASCP, MLS(ASCP)CMSHCM

Sr. IT Technical Specialist & Test Master
LabCorp, Burlington, NC

Michael S. Barr, MD, MBA, FACP

Senior Vice President
Division of Medical Practice, Professionalism & Quality
American College of Physicians, Washington, DC

Jon M. Lipsky, MBA, PMP, CSM

President, J Michael Consulting, LLC
Contractor to the Association of Public Health Laboratories
Woodstock, GA

Suzanne Butch, MA, MT(ASCP)SBB, CQA(ASQ)

Administrative Manager for Healthcare,
Blood Bank & Transfusion Service
University of Michigan, Ann Arbor, MI

Ulrike Riki Merrick, MPH

Public Health Information Specialist, iConnect Consulting
Contractor to the Association of Public Health Laboratories
Carmichael, CA

Joseph M. Campos, PhD, D(ABMM), F(AAM)

Director, Microbiology Laboratory, Molecular Diagnostics
Laboratory, and Laboratory Informatics
Childrens National Medical Center, Washington, DC

Timothy J. Ryan, MBA

Director of Enterprise Application Integration Services Quest
Diagnostics Incorporated, Madison, NJ

Alexis B. Carter, MD
Director of Pathology Informatics
Emory University School of Medicine, Atlanta, GA

Hardeep Singh, MD, MPH

Chief, Health Policy and Quality Program, Houston VA
HSR&D Center of Excellence, Michael E. DeBakey Veterans Affairs
Medical Center and Baylor College of Medicine, Houston TX

Adam Cheriff, MD
Chief Medical Information Officer
Weill Cornell Physician Organization, New York,NY

Shaman Singh, MD
Enterprise Systems Manager for Health Provider Systems
Veterans Health Administration, Washington, D.C.

JohnFontanesi,PhD
Director, Center for Management Science in Health
University of California, San Diego School of Medicine
La Jolla, CA

Brent Steineckert, MPH, PMP

Ambulatory EHR/HIM/Pt Access Director
Sharp Rees-Stealy Medical Group, San Diego, CA

Alvin Hoover, FACHE

Chief Executive Officer
Kings Daughters Medical Center, Brookhaven, MS

J. Mark Tuthill, MD
Division Head, Pathology Informatics
Henry Ford Health System, Detroit, MI

Additional White Paper Reviewers

Raymond D. Aller, MD, FACMI, FHIMSS
Clinical Professor and Director of Informatics
USC Department of Pathology,
Los Angeles, CA
Keck School of Medicine, Vista, CA

Anand Dighe, MD,PhD

Director, Department of Pathology
Massachusetts General Hospital
Core Laboratory
Boston, MA

Walter Henricks, MD
Director, Center for Pathology Informatics
Cleveland Clinic,
Cleveland, OH

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Ensuring the Safety and Effectiveness of Laboratory Data in Electronic Health Record Systems

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